UNISHIELD PAIN ZAPPER- acetaminophen, aspirin, caffeine, salicylamide tablet

Unishield Pain Zapper by

Drug Labeling and Warnings

Unishield Pain Zapper by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Aspirin (NSAID)* 162 mg

Caffeine 32.4 mg

Salicylamide (NSAID)* 152 mg

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Adjuvant

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

t emporarily relieved minor aches and pains associated with

■ headaches ■ muscular aches ■ minor arthritis pain ■ back pain ■ colds ■ toothache ■ menstrual cramps

Temporarily reduces fever.

WARNINGS

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin and Salicylamide may cause a severe allergic reaction which may include:

■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin or allergic reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains nonsteroidal anti-inflammatory drugs (NSAIDs), which may cause severe stomach bleeding. The chance is higher if you:

■ are age 60 or older

■ have had stomach ulcers or bleeding problems

■ take a blood thinning (anticoagulant) or steroid drug

■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

■ have 3 or more alcoholic drinks every day while using this product

■ take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat

DO NOT USE

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
drug contains acetaminophen, ask a doctor or pharmacist.

■ for pain for more than 10 days unless directed by a doctor

■for more than 3 days for fever unless directed by a doctor

■ with any other pain reliever/fever reducerl)

ASK DOCTOR

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have a history of stomach problems (such as heartburn, upset stomach or stomach pain)

■ you have heart disease, liver cirrhosis, or kidney disease

■ you have asthma or high blood pressure

■ you are taking a diuretic

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ anticoagulation

■ diabetes

■ gout

■ arthritis

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you have

■ liver disease

WHEN USING

When using this product do not exceed recommended dose

STOP USE

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better

■ symptoms do not improve

■ pain or fever gets worse

■ ringing in the ears or loss of hearing occurs

■ new symptoms occur

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin and salicylamide during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

■ do not use more than directed

Adults and children(12 years and older): take 2 tablets every 4 hours as needed with a full glass of water. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

Children under 12 years of age: Ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid.

QUESTIONS

Questions or Comments? 800-480-5855

Unishield Pain Zapper Label

Unishield

Pain Zapper

Extra Strength Pain Relief

100 Tablets/ 2 Tablets Per Packet

Acetaminophen 110 mg. Aspirin (NSAID) 162 mg

Caffeine 32.4 mg. Salicylamide (NSAID) 152 mg

Pull To Open

This Package is for Households wirhout Young Children.

Fast effective relief from tough headaches

Non-drowsy formula contains caffeine

Fast Acting Advanced Formula

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

UNISHIELD PAIN ZAPPER 
acetaminophen, aspirin, caffeine, salicylamide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-8113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	162 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC)	SALICYLAMIDE	152 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	110 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.4 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-8113-3	50 in 1 BOX	03/01/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/01/2021

Labeler - Unishield (790677053)

Registrant - Unifirst First Aid Corporation (832947092)